GLYCOPYRROLATE
- Product NDC
- 13107-014
- 11-digit product format
- 131070014
- Labeler code
- 13107
- Product ID
- 13107-014_1ec6c3c1-ed9c-481e-bcc0-bafb7f5c0448
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- GLYCOPYRROLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA202675
- Marketing category
- ANDA
- Marketing start
- 2023-02-28
- Substance
- GLYCOPYRROLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GLYCOPYRROLATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLYCOPYRROLATE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V92SO9WP2I |
| Rxcui | 197738, 197739 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 13107-014-01 | 2023-03-24 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-10 | 2023-03-24 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-11 | 2023-03-24 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-99 | 2023-03-24 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-10 | 2023-01-30 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-11 | 2023-01-30 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
| 13107-014-99 | 2023-01-30 | C162847 | 48780-1 | f386c649-d84d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use GLYCOPYRROLATE TABLETS safely and effectively. See full prescribing information for GLYCOPYRROLATE TABLETS. GLYCOPYRROLATE tablets, for oral use Initial U.S. Approval: 1961 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-014-01 | GLYCOPYRROLATE | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-014 | GLYCOPYRROLATE TABLET [AUROLIFE PHARMA LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240820_677f8495-a870-45b6-bb65-75b449f040ce.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13107-014-01 | 13107001401 | 100 TABLET in 1 BOTTLE (13107-014-01) | 100 tablet | 2023-02-28 | 0000-00-00 | No | No | Current |
| 13107-014-10 | 13107001410 | 10 BLISTER PACK in 1 CARTON (13107-014-10) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2013-04-15 | 0000-00-00 | No | No | Current |
| 13107-014-11 | 13107001411 | 10 TABLET in 1 BOTTLE (13107-014-11) | 10 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |
| 13107-014-99 | 13107001499 | 1000 TABLET in 1 BOTTLE (13107-014-99) | 1000 tablet | 2013-04-15 | 0000-00-00 | No | No | Current |